UNITED STATES: FDA Panel Set to Weigh New Female Condom

Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.

UNITED STATES: FDA Panel Set to Weigh New Female Condom

Reuters (12.09.08) - Thursday, December 11, 2008
Susan Heavey

On Thursday, a Food and Drug Administration advisory panel is set to review a new, potentially less expensive version of the female condom. The panel of outside experts will consider whether the FC2 Female Condom, made by Chicago-based Female Health Co., adequately prevents pregnancy, HIV, and other STDs.

Female Health already has a female condom on the US market. However, the new version is made with a synthetic rubber and uses a process similar to male condoms that the company says is less labor intensive and should reduce its cost. Female condoms currently cost between $2.80 and $4 each, compared to 50 cents to $2 for male condoms.

"The whole idea is to increase access," said Mary Ann Leeper, an adviser and former president of Female Health.

However, FDA regulatory staff questioned whether the company should have conducted specific trials to demonstrate FC2's effectiveness. Female Health said it did not conduct such studies because while FC2 uses a new material it is otherwise similar to the version already on the market, according to FDA documents released Tuesday. "This is an important review issue," FDA staff wrote.

Both female condoms include a sheath with a closed ring on one end that is inserted near the cervix and an open ring on the outer end that remains outside the woman's body, covering the outer genitals. The original version uses polyurethane, while the new one is made of nitrile.

According to Leeper, conducting another trial would have taken five more years and cost millions of dollars. "The design is exactly the same, how you use it is exactly the same, we just don't believe there is any more information required," she said.
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